Table 4. Renal safety parameters at week 144.
| TAF (N = 227) | TDF (N = 107) | |
|---|---|---|
| Mean serum creatinine (mg/dL [SD]) | ||
| Baseline | 0.81 (0.144) | 0.82 (0.151) |
| Change at week 144 | –0.012 (0.090) | –0.002 (0.092) |
| Difference in least squares means (95% CI) | –0.011(−0.033–0.010) | |
| Median eGFRCG (mL/min [Q1, Q3]) | ||
| Baseline | 113 (98, 129) | 113 (97, 125) |
| Change at week 144 | –0.4 (–8.2, 8.6) | –3.2 (–11.2, 5.2) |
| p-value | 0.014 | |
| ≥25% decrease from baseline in eGFRCG (n/n) | 22/225 (10) | 24/107 (22) |
| p-value | 0.003 | |
| Shifts in CKD stage: baseline →week 144*† | ||
| Improvement | ||
| Stage 2→1 | 7/32 (22) | 1/12 (8) |
| Stage 3→2 | 1/1 (100) | 0/2 (0) |
| Worsening | ||
| Stage 1→2 | 12/180 (7) | 10/85 (12) |
| Stage 2→3 | 0/32 (0) | 0/12 (0) |
| No change | ||
| Stage 1→1 | 168/180 (93) | 75/85 (88) |
| Stage 2→2 | 25/32 (78) | 11/12 (92) |
| Stage 3→3 | 0/1 (0) | 2/2 (100) |
| p-value | 0.064 | |
| Median urinary proximal tubular markers (µg/g [Q1, Q3]) | n = 227 | n = 107 |
| RBP:Cr | ||
| Baseline | 91 (65, 133) | 93 (69, 138) |
| % change at week 144 | –8 (–35, 41) | 27 (–18, 71) |
| p-value | 0.003 | |
| β2M:Cr | ||
| Baseline | 94 (67, 152) | 91 (58, 149) |
| % change at week 144 | –29 (–56, 12.5) | 18 (–35, 124) |
| p-value | <0.0001 | |
eGFRCG, estimated creatinine clearance by the Cockcroft-Gault method. RBP:Cr, urine retinol binding protein-to-creatinine ratio. β2M:Cr, urine beta-2 microglobulin to creatinine ratio. *eGFRCG: Stage 1: ≥ 90 mL/min; Stage 2: ≥60 to < 90 mL/min; Stage 3: ≥ 30 to < 60 mL/min; Stage 4:≥15 to <30 mL/min. †There were no Stage 4 CKD patients at baseline and no patients had moved to Stage 4 at week 144.